Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 10:24 AM
Study NCT ID:
NCT04238156
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2020-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-20', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-18', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Diastasis - Baseline', 'timeFrame': 'Pre-intervention', 'description': 'Supraumbilical distance between the rectus abdominis\n\n* Assessment tool: caliper (electronic, calibrated, precision: 1 mm)\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Abdominal Diastasis - post-intervention 1', 'timeFrame': 'Immediately after the intervention', 'description': 'Supraumbilical distance between the rectus abdominis\n\n* Assessment tool: caliper (electronic, calibrated, precision: 1 mm)\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Abdominal Diastasis - post-intervention 2', 'timeFrame': 'One month after the intervention', 'description': 'Supraumbilical distance between the rectus abdominis\n\n* Assessment tool: caliper (electronic, calibrated, precision: 1 mm)\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Abdominal Diastasis - post-intervention 3', 'timeFrame': 'Two months after the intervention', 'description': 'Supraumbilical distance between the rectus abdominis\n\n* Assessment tool: caliper (electronic, calibrated, precision: 1 mm)\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}], 'secondaryOutcomes': [{'measure': 'Abdominal tonometry - Baseline', 'timeFrame': 'Pre-intervention', 'description': 'Tonometric evaluation on the white line (linea alba) and the abdominal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Perineal tonometry - Baseline', 'timeFrame': 'Pre-intervention', 'description': 'Tonometric evaluation on the perineal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Waist circumference - Baseline', 'timeFrame': 'Pre-intervention', 'description': 'Waist circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: minimum perimeter'}, {'measure': 'Chest circumference - Baseline', 'timeFrame': 'Pre-intervention', 'description': 'Chest circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: maximum perimeter'}, {'measure': 'Abdominal tonometry - post-intervention 1', 'timeFrame': 'Immediately after the intervention', 'description': 'Tonometric evaluation on the white line (linea alba) and the abdominal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Perineal tonometry - post-intervention 1', 'timeFrame': 'Immediately after the intervention', 'description': 'Tonometric evaluation on the perineal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Waist circumference - post-intervention 1', 'timeFrame': 'Immediately after the intervention', 'description': 'Waist circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: minimum perimeter'}, {'measure': 'Chest circumference - post-intervention 1', 'timeFrame': 'Immediately after the intervention', 'description': 'Chest circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: maximum perimeter'}, {'measure': 'Abdominal tonometry - post-intervention 2', 'timeFrame': 'One month after the intervention', 'description': 'Tonometric evaluation on the white line (linea alba) and the abdominal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Perineal tonometry - post-intervention 2', 'timeFrame': 'One month after the intervention', 'description': 'Tonometric evaluation on the perineal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Waist circumference - post-intervention 2', 'timeFrame': 'One month after the intervention', 'description': 'Waist circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: minimum perimeter'}, {'measure': 'Chest circumference - post-intervention 2', 'timeFrame': 'One month after the intervention', 'description': 'Chest circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: maximum perimeter'}, {'measure': 'Abdominal tonometry - post-intervention 3', 'timeFrame': 'Two months after the intervention', 'description': 'Tonometric evaluation on the white line (linea alba) and the abdominal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Perineal tonometry - post-intervention 3', 'timeFrame': 'Two months after the intervention', 'description': 'Tonometric evaluation on the perineal muscles\n\n* Assessment tool: (MyotonPro (R))\n* Subject position: supine\n* Localization: 3 cm, 6 cm, 9 cm, 12 cm supraumbilical'}, {'measure': 'Waist circumference - post-intervention 3', 'timeFrame': 'Two months after the intervention', 'description': 'Waist circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: minimum perimeter'}, {'measure': 'Chest circumference - post-intervention 3', 'timeFrame': 'Two months after the intervention', 'description': 'Chest circumference\n\n* Assessment tool: tape measure (flexible, precision: 1mm)\n* Subject position: standing\n* Localization: maximum perimeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum', 'Hypopressive abdominal exercises', 'Pelvic floor muscles'], 'conditions': ['Abdominal Diastasis']}, 'descriptionModule': {'briefSummary': 'The prevalence of abdominal diastasis is high in postpartum. The abdominal diastasis can impair the body posture, the of lumbo-pelvic stability and movement, or breathing. Exercises focused on the transversus abdominis muscle have been proposed as a therapeutic approach for abdominal diastasis.\n\nHypopressive abdominal exercises have been used for postpartum recovery, for specific pathologies related to pregnancy (low back pain, pelvic floor dysfunction ...) and even for the rehabilitation of spinal pathologies. However, there is a lack of studies that determine its effectiveness and clinical utility.\n\nThe aim of the study will be to analyze the effects of Hypopressive abdominal exercises on postpartum abdominal diastasis, the tone of the transverse abdominal muscle and the pelvic floor musculature.\n\nA case series design will be applied, with weekly assessment of the outcomes after the intervention and two months after the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primiparous or multiparous\n* abdominal diastasis previously diagnosed\n* commitment to perform, at least, 80% of the exercises\n* signed informed consent\n\nExclusion Criteria:\n\n* BMI \\> 40 Kg/m2\n* pelvic floor disorders before childbirth\n* drugs with effects on continence or functional properties of the pelvic floor muscles\n* treatment for abdominal diastasis in the last 6 months\n* systemic disease that impairs pelvic floor physiology and urination\n* menopause\n* contraindications to the practice of physical exercise and physical therapy'}, 'identificationModule': {'nctId': 'NCT04238156', 'acronym': 'HipoDiastasi', 'briefTitle': 'Hypopressive Abdominal Exercise in Postpartum Abdominal Diastasis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Córdoba'}, 'officialTitle': 'Hypopressive Abdominal Exercise Effectiveness in Postpartum Abdominal Diastasis, Tone of the Transverse Muscle and the Pelvic Floor Muscles - Case Series', 'orgStudyIdInfo': {'id': 'HipoDiastasis4073-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypopressive abdominal exercises', 'description': 'Hypopressive abdominal exercises will be performed in basic postures (standing, sitting and supine position). In each posture, three slow cost-diaphragmatic respiration will be performed followed by an expiratory apnea and a rib cage opening, during 2 to 10 seconds, and an exhalation of 10 to 30 seconds. Each exercise will be repeated three times.\n\nThere will be 3 stages of application throughout the 12 intervention sessions, supervised by a physical therapist:\n\nFirst stage: To explain the concept of hypopressive respiration and how to perform it.\n\nSecond stage: To explain and apply the hypopressive abdominal exercises: 1. Axial auto-elongation (reducing curvatures in the sagittal plane); 2. Cervical auto-elongation (chin toward the neck); 3. Moving forward of gravity axis; 4. Activation of the shoulder girdle (shoulder joint decoaptation); 5. Slight knee flexion; 6. Dorsal ankle flexion.\n\nThird stage: To review and update all the exercises, increasing their intensity.', 'interventionNames': ['Other: Hypopressive abdominal exercises']}], 'interventions': [{'name': 'Hypopressive abdominal exercises', 'type': 'OTHER', 'description': 'Three sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes.', 'armGroupLabels': ['Hypopressive abdominal exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'University of Córdoba', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Daiana Priscila Rodrigues-de-Souza, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Córdoba'}, {'name': 'Miriam Ramírez Jiménez, Phys Ther', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Córdoba'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Córdoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph D, Associate Professor', 'investigatorFullName': 'Francisco Alburquerque-Sendín', 'investigatorAffiliation': 'Universidad de Córdoba'}}}}